Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

• Main Authors: Peter J. Kilford (Author), Kuan‐Fu Chen (Author), Kim Crewe (Author), Iain Gardner (Author), Oliver Hatley (Author), Alice Ban Ke (Author), Sibylle Neuhoff (Author), Mian Zhang (Author), Karen Rowland Yeo (Author)
• Format: Book
• Published: Wiley, 2022-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Physiologically‐based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug-drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending, or indeed requesting, more rigorous demonstration of the...